Coronary Arterial Disease (CAD)Phase 2/3HEART-BEATNCT07268170
Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease
A Phase 2/3 study testing atenolol, Metoprolol tartrate and Ivabradine in people with Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to describe which type and dose of commonly used heart rate reducing drugs (metoprolol, atenolol, or ivabradine) has the swiftest heart rate reduction from baseline in patients aged 30 to 80 years with a heart rate > 65 beats per minute undergoing cardiac computed tomography for the… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD)
- What is being tested?
- atenolol, Metoprolol tartrate and Ivabradine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2025to 30 Sep 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are to undergo Cardiac CT
- Sinus rhythm with heart rate > 65 bpm on ECG
- Competent patients who have given written informed consent
Who cannot join
- Age > 80 years
- Age < 30 years
- Heart rate > 100 bpm
- BMI > 35
- Previous percutaneous coronary intervention (with or without stent)
- Previous CABG
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- Known ischemic heart disease
- Pacemaker
- Acute coronary syndrome
- Known allergy to beta-blockers
- Known allergy to ivabradine
- Known allergy to used radiographic contrast agents
- Pregnant, including potentially pregnant, or breastfeeding (potentially pregnant patients will undergo pregnancy testing)
- Heart failure with systolic left ventricular ejection fraction < 45%
- Reduced kidney function with estimated glomerular filtration rate (eGFR) < 40 ml/min
- Regular treatment with beta-blockers
- Regular treatment with ivabradine
- Regular treatment with non-dihydropyridine calcium antagonists (Verapamil and Diltiazem)
- Regular treatment with Cordarone
- Contraindications for beta-blockers or ivabradine:
- Severe asthma
- Severe COPD
- Sick sinus syndrome
- Sinoatrial block (1st degree AV block)
- Advanced AV block (2nd or 3rd degree)
- Hypotension (systolic blood pressure < 110 mmHg)
- Severe heart failure
- Severe restrictive cardiomyopathy
- Severe aortic stenosis
- Severe circulatory disturbances
- Severe metabolic conditions
- Untreated pheochromocytoma
- Concurrent treatment with potent inhibitors of CYP3A4
- Concurrent treatment with potent inhibitors of MAO inhibitors,
- Concurrent treatment with potent inhibitors of CYP2D6 inhibitors
- Concurrent treatment with potent inhibitors of intravenous calcium antagonists type I or III
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Heart Rate Control: Betablockers or Ivabradine Therapy Before Cardiac Computed Tomography
The goal of this clinical trial is to describe which type and dose of commonly used heart rate reducing drugs (metoprolol, atenolol, or ivabradine) has the swiftest heart rate reduction from baseline in patients aged 30 to 80 years with a heart rate > 65 beats per minute undergoing cardiac computed tomography for the evaluation of coronary artery disease. The main question it aims to answer is
- Which type of heart reducing drug and dose has the swiftest heart rate reduction before cardiac computed tomography?
Read the detailed description
This single-center, prospective, randomized, double-blind, clinical trial will include patients undergoing cardiac computed tomography. Two phases will be conducted: a pilot study (dose-finding phase) and a randomized trial (superiority phase). In the first dose-finding phase participants (N=150) will be randomized 1:1 in six arms (arms contain lower and higher doses of atenolol, metoprolol and ivabradine). Following an interim analysis, a superiority phase will be conducted using two parallel groups, non-diabetics (N=100) and diabetics (N=100), in a placebo-controlled head-to-head randomized 2:2:1 three-arms trial comparing the fastest betablocker and dose and the fastest dose of ivabradine from the dose-finding phase.
- Being tested
- atenolol, Metoprolol tartrate, Ivabradine, Atenolol/Metoprolol tartrate, Ivabradine 7.5/15 mg
- Keywords
- Cardiac computed tomography, premedication, metoprolol, ivabradine, atenolol, heart rate control, heart rate
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atenololDrug
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Metoprolol tartrateDrug
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
IvabradineDrug
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Atenolol/Metoprolol tartrateDrug
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Ivabradine 7.5/15 mgDrug
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Metoprololtartrat 50 mg | Experimental | Strategy 1 Receives: Drug: atenolol; Drug: Ivabradine |
| Metoprololtartrat 100 mg | Experimental | Strategy 1 Receives: Drug: atenolol; Drug: Ivabradine |
| Atenolol 50 mg | Experimental | Strategy 1 Receives: Drug: Metoprolol tartrate; Drug: Ivabradine |
| Atenolol 100 mg | Experimental | Strategy 1 Receives: Drug: Metoprolol tartrate; Drug: Ivabradine |
| Ivabradine 15 mg | Experimental | Strategy 1 Receives: Drug: atenolol; Drug: Metoprolol tartrate |
| Ivabradine 7.5 mg | Experimental | Strategy 1 Receives: Drug: atenolol; Drug: Metoprolol tartrate |
| Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg) | Experimental | Strategy 2 Receives: Drug: Ivabradine 7.5/15 mg |
| Fastest dose of Ivabradine (Ivabradine 7.5/15 mg) | Experimental | Strategy 2 Receives: Drug: Atenolol/Metoprolol tartrate |
| Placebo | Placebo comparator | Strategy 2 Receives: Drug: Atenolol/Metoprolol tartrate; Drug: Ivabradine 7.5/15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography
Time in minutes to heart rate (mean) lowered by 10% from baseline after administration of study drug
Measured: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Secondary outcomes (5)
Proportion of patients with heart rate <60 beats per minute
Measured: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Total heart rate reduction in beats per minute after 120 minutes
Measured: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Number of patients in need of an intravenous betablocker
Patients with a heart rate >60 beats per minutes after 2 hours after administration of study drug
Measured: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Efficacy of intravenous administration of betablocker
How patients tolerate intravenous betablocker
Measured: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Evaluation of side effects, safety, and tolerability of metoprolol, atenolol, and ivabradine
Phone contact to patient to describe any side effects and the tolerability
Measured: From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Initial dose-finding pilot study using a controlled, double-blind, 6 armed 1:1 randomized design. Followed by a sequential controlled, double-blind, placebo-controlled study of most effective betablocker and ivabradine dose among a subgroup of diabetics and non-diabetics undergoing cardiac computed tomography.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten Böttcher, Professor, Study chair, University Clinic of Ishemic Heart Disease, Gødstrup HospitalSimon Winther, MD, PhD, Principal investigator, University Clinic of Ishemic Heart Disease, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268170
- Sponsor's protocol ID
- 2025-522741-21-00
- Other IDs
- 2025-522741-21-00, 2025
- Acronym
- HEART-BEAT
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. All data will be analyzed and managed locally at our site, and we do not plan to share IPD.